|
No. |
Topic |
Summary |
Pages |
8531
| Current Regulatory Requirements for Specifications (ICH Q6A) | - | 77 |
8532
| Current Regulatory Requirements for Specifications of Biotech Products/Well-Characterised Biologicals (ICH Q6B) | - | 34 |
8533
| Development and Justification of Specifications for the Assay of APIs | - | 31 |
8534
| Rational Development and Justification for Acceptance Criteria for Impurities | - | 44 |
8535
| Workshop: Specifications for APIs: Evaluating Organic Impurities | - | 3 |
8536
| Workshop: Impurities in Biological Products | - | 21 |
8537
| Specifications in Stability Testing | - | 18 |
8538
| Specifications in the New Paradigm | - | 53 |
8539
| Rational Development and Justification of Acceptance Criteria for the Assay of the API in Drug Products | - | 42 |
8540
| Workshop: Specifications for Drug Products containing chemically manufactured APIs | - | 6 |
8541
| Specifications for Biopharmaceutical Drug Products | - | 54 |
9152
| Dossier Requirements for Setting Specifications | - | 42 |
9153
| Handling Changes / Variations during development and after gaining an MAA | - | 27 |
